STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room

Официальное название

STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room

Обзор

The purpose of the study is to test the impact of the StOP?-protocol - an intra-operative communication briefing, on post-operative mortality and important patient outcomes.

Подробное описание

The StOP?-protocol is a communication briefing initiated by the responsible surgeon during a surgical operation. The surgeon informs the team present in the operating room about the current Status of the operation, the Objectives of the next steps and the potential Problems the surgical team may meet; the responsible surgeon encourages the team to voice any question or concern (?).

To test the impact of the StOP?-protocol on patient outcomes, the study is designed as a randomized controlled trial. Surgeons will be randomized either (a) in the intervention group and be trained to perform the StOP?-protocol or (b) in the control group and will communicate as they prefer during their operations. Post-operative patient outcomes of the surgeons in the intervention and the control group will be compared to evaluate the effects of the StOP?-protocol.

Вмешательства

• Поведенческое StOP?-protocol
  The StOP?-protocol is an intra-operative briefing initiated by the responsible surgeon. When performing a StOP?-protocol, the surgeons inform the team present in the operating room about the Status (St) of the operation, the Objectives (O) of the operations, the potential problems (P) they may meet and encourage the team to ask questions or voice concerns (?). The responsible surgeon announces at the team timeout when they plan to perform the StOP-protocol(s).

Первичные конечные точки

• Mortality within 30 days after the operation [Срок оценки: 30 days after the index operation]

Вторичные конечные точки (3)

• Unplanned reoperations within 30 days after the operation [Срок оценки: 30 days after the index operation]
• Length of hospital stay [Срок оценки: It is reasonable to estimate that the information will be available after 60 post-operative days for most patients]
• Unplanned hospital readmissions within 30 days after the operation [Срок оценки: 30 days after the index operation]

Критерии участия

For the clusters (surgeons)

Критерии включения

• Board-certified surgeons with specialization in one of the following disciplines: general, visceral, thoracic, vascular surgery, surgical urology, or gynecology.

Критерии исключения

• Surgeons who are already performing StOP?-protocol. (Potentially, surgeons who took part in the first study (StOP-I) may still perform StOP?).
• Surgeon who were previously enrolled in the StOP?-II trial (this is relevant for surgeons who move or rotate between departments/hospitals and might therefore be working at different participating sites).

For the patients:

Критерии включения

• Patients operated by cluster surgeons during the cluster-specific time period
• General consent from the patients, allowing the use of healthcare-related data that are the result of the patient's treatment. In case no written document from the general consent is available despite documented efforts of the participating center, article 34 HRA (Swiss law) will be applied, allowing the use of the healthcare-related patient data.

Критерии исключения

• Patient age below 18 years
• Previous operation at the same site up to 30 days prior the index operation
• Procedures not done in operating rooms but in outpatient clinics, on wards, etc.
• Mainly diagnostic endoscopic procedures (e.g. colonoscopy, gastroscopy, bronchoscopy)
• Percutaneous interventions (e.g., transurethral interventions)
• Documented refusal for the use of healthcare related data

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Швейцария · 12 центров

• Kantonsspital Baselland — Liestal
• Kantonsspital Baden AG — Baden
• Bern University Hospital (Inselspital) — Bern
• Hôpital Fribourgeois — Fribourg
• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne
• Spital Limmattal — Schlieren
• Kantonsspital Winterthur — Winterthur
• Stadtspital Zürich Triemli — Zurich
• … и ещё 4 центра

Австрия · 1 центр

• Tirol Kliniken GmbH — Innsbruck

Публикации

• Keller S, Tschan F, Semmer NK, Trelle S, Manser T, Beldi G. StOP? II trial: cluster randomized clinical trial to test the implementation of a toolbox for structured communication in the operating room-study protocol. Trials. 2022 Oct 18;23(1):878. doi: 10.1186/s13063-022-06775-y. PMID 36258223

Идентификаторы

NCT: NCT05356962 · 2021-02433

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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